lent vaccines, live attenuated vaccinia virus, and modified vaccinia In this paper, we review the key elements that must be considered Ankara strain were initiated. In 1980, this formerly deadly patho- to take a novel vaccine from the laboratory through to licensure in gen was declared eradicated globally. 1 In the United States, licensed the modern era. First, we vaccines are available for over 25 pathogens. Worldwide, vaccina- discuss the host immune response that we engage with vaccines.
Innate degrade the antigen-Ab complex. This process is called neutral- immune cells recognize “foreign” components of pathogens ization. Effective neutralizing antibodies (NAbs) can completely collectively described as pathogen- a ssociated molecular prevent systemic or disseminated infection by a pathogen. Non- patterns (PAMPs). 13 PAMPs can derive from all parts of the neutralizing antibodies also exist. These antibodies still bind to pathogen, including lipopolysaccharide and peptidoglycans the pathogens but do not interfere with their infectivity. Non- in the bacterial cell wall, viral RNA, and DNA. PAMPs bind neutralizing antibodies can contribute to protective immunity by to ligands in host cells, called pattern recognition receptors augmenting clearance of infected cells or inducing complement.
edu) Received January 7, 2021; accepted February 9, 2021. doi:10. 1002/cpt. 2207 CLINICAL PHARMACOLOGY & THERAPEUTICS | VOLUME 109 NUMBER 4 | April 2021 987 TUTORIAL (PRRs), to rapidly induce a range of innate responses, including Box 1 Herd immunity the production of antiviral molecules, such as interferons, Herd immunity describes a level of immunity within a com- synthesis of chemokines, like MIP-1β and phagocytosis, to munity, whether produced through natural infection or vac- engulf, degrade, and clear the pathogen (reviewed in ref. 14). cination, that is sufficient to reduce pathogen spread below PRRs include toll-like receptors (TLR), mannose receptors, a “critical point. ” Roy and May described the critical point NOD- l ike receptors, and RIG- I- l ike receptors. PRRs are being achieved in a community where, on average, an infected expressed by innate immune cells, which include dendritic person infects less than one other person.
tion programs are estimated to save between 2 and 3 million lives Second, we discuss the in vivo and in invitro studies that inform annually and limit morbidity in 10s of millions. Vaccination pro- vaccine design. Third, we discuss different vaccine modalities that grams also provide enormous economic savings. 2 have been licensed or are in testing in humans. Last, we overview There are diseases against which preventative vaccines have not the basic principles of vaccine approvals.
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Recent studies are now The design of a subunit immunogen is influenced by many trialing “universal” influenza vaccines targeting the more conserved factors, informed by natural history studies. The most important hemagglutinin stalk. 72 is whether the correlate of protection is predicted to mostly rely HIV immunogen design encompasses all the factors mentioned on humoral or T cell-mediated immunity.
and metagenomics analysis. 10 Viral sequences were then aligned By contrast, natural infection studies of HIV have supported with publicly available databases to show the new pathogen was a greater focus on the development of T cell vaccines. The high closely related to SARS-CoV, which caused an epidemic in 2002– mutation, recombination, and replication rates of HIV enable the 2004 that infected lungs via the ACE-2 receptor. 42 Subsequent generation of escape mutations against adaptive immune responses studies found that SARS-CoV-2, like SARS-CoV, could be propa- in natural infection. 35 HIV can tolerate extensive mutation in its gated ex vivo in cell lines transduced with human ACE-2, 43, 44 and surface Envelope protein, limiting the success of humoral vaccines in vitro infection could be prevented by antibodies targeting the to date.
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comparison of vaccine modalities. Second, informative procedures, The animals most commonly used in research are inbred not possible in humans, can be performed. For example, CD8-Ab mice, which have a large selection of reagents available for study. depletion following simian immunodeficiency virus infection led Moreover, mice are small, facilitating rapid and iterative testing. to increased viremia in rhesus macaques, supporting human stud- Other rodent models include rabbits, guinea pigs, and hamsters, ies that CD8+ T cells were important for control of HIV, in turn, although these have fewer reagents available.
g., i. m. must be manufactured. vs. i. d. n. ), (iii) different intervals between booster doses, (iv) The COVID-19 pandemic has identified mRNA vaccines as different study populations—typically, beginning with lowest risk a powerful vaccine vector platform capable of inducing potent groups, and (v) also the impact of different adjuvants. This process bNAbs and T cell immunity. 62 Microbial mRNA has potent ad- typically takes more than 10 years. Critically, the lessons learned juvant activity stimulating TLR-3 and -7 expressed by APCs.
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from these studies can greatly accelerate vaccine development Although long-term safety testing is ongoing, in theory, mRNA against a new pathogen. When SARS-CoV-2 was identified, re- vaccines will be fully degraded by host RNAases and therefore are searchers at the University of Oxford had been testing attenuated safe. mRNA vaccines will likely be used increasingly to target other viral vectors in people for 20 years. 90–103 This work had identified diseases. chimpadenovirus vectors as safe and strongly immunogenic, induc- ing both humoral and T cell immunity in different study popula- Production and delivery.
It is weeks of the identification of the SARS-CoV-2 sequence, a poly- therefore critical that natural history cohorts reflect all population merase chain reaction-based diagnostic test was available. 48 This demographics, most critically age. The strength of the adaptive im- and other tests not only greatly improved clinical care but enabled mune response is very closely linked with age. Relative to otherwise the enrollment of participants in study cohorts for natural history CLINICAL PHARMACOLOGY & THERAPEUTICS | VOLUME 109 NUMBER 4 | April 2021 991 studies.
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